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Virtual Assistant for COVID-19 PPE

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Assistant first, then Human Coach
Human Coach first, then Virtual Assistant
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring PPE adherence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Only anesthesia attending staff are allowed in the phase 1 study.
  • Any working anesthesia staff and fellow, anesthesia assistant, respiratory assistant and operating room nurse are qualified to take part in phase 2 of this study. However, only anesthesia staff and fellows and anesthesia assistants will participate in the part that involves intubation and extubation.

Exclusion Criteria:

• Unwillingness to enter the study for phase 1 or phase 2.

Sites / Locations

  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Donning PPE using VA then doffing PPE using HC

Donning PPE using HC then doffing PPE using VA

Intubation using VA then extubation using HC;

Intubation using HC then extubation using VA

Arm Description

Study subjects will receive VA guidance for donning first, then guidance from a human coach (HC) for doffing.

Study subjects will receive HC guidance for donning first, then VA guidance for doffing.

Study subjects will receive VA guidance for the intubation first , then HC guidance for extubation procedure

Study subjects will receive HC guidance for the intubation first , then VA guidance for extubation procedure

Outcomes

Primary Outcome Measures

performance of healthcare workers
Errors occurred during donning of PPE measured by procedure checklist
performance of healthcare workers
Errors occurred during doffing of PPE measured by procedure checklist
performance of healthcare workers
Errors occurred during intubation measured by procedure checklist
performance of healthcare workers
Errors occurred during extubation measured by procedure checklist

Secondary Outcome Measures

Full Information

First Posted
June 9, 2020
Last Updated
January 7, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04435275
Brief Title
Virtual Assistant for COVID-19 PPE
Official Title
Development of an Automated and Scalable Virtual Assistant to Aid in PPE Adherence and Clinical Protocols for Healthcare Worker Safety
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2021 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The COVID virus is acquired through droplet and micro droplet transmission. Although healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure to the virus and avoid contamination, the assumption that everyone can precisely remember every step is improbable as many of these procedures are quite complex and involve multiple steps in stressful situations. Further the use of a trained safety officer to ensure adherence is not always feasible due to the ever growing demand of healthcare providers. Investigators propose to utilize the Amazon Alexa device and Alexa Skills application to develop a voice enabled virtual assistant to guide healthcare professionals through the exact steps of clinical procedures including the donning and doffing of PPE, intubation and extubation procedures. Methods A total of 10 staff anesthesiologists will be recruited to participate in phase 1 of the study to evaluate the utility and functionality of this VA device. A total of 40 healthcare professionals will be recruited to participate in phase 2 of the study. Anesthesia providers (staff and fellows), anesthesia assistants, respiratory assistants and operating room nurses will be randomized to receive instructional guidance by the VA on one test occasion and a human coach on another occasion. During this phase of the study, the effectiveness of this VA prototype will be compared with a trained human safety officer / coach in its ability to provide instructional guidance for 4 safety and clinical procedures: 1) proper donning of personal protective equipment (PPE); 2) doffing of PPE; 3) intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
PPE adherence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donning PPE using VA then doffing PPE using HC
Arm Type
Active Comparator
Arm Description
Study subjects will receive VA guidance for donning first, then guidance from a human coach (HC) for doffing.
Arm Title
Donning PPE using HC then doffing PPE using VA
Arm Type
Active Comparator
Arm Description
Study subjects will receive HC guidance for donning first, then VA guidance for doffing.
Arm Title
Intubation using VA then extubation using HC;
Arm Type
Active Comparator
Arm Description
Study subjects will receive VA guidance for the intubation first , then HC guidance for extubation procedure
Arm Title
Intubation using HC then extubation using VA
Arm Type
Active Comparator
Arm Description
Study subjects will receive HC guidance for the intubation first , then VA guidance for extubation procedure
Intervention Type
Other
Intervention Name(s)
Virtual Assistant first, then Human Coach
Intervention Description
Instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a VA (e-coach) in place of a safety officer (a human coach).
Intervention Type
Other
Intervention Name(s)
Human Coach first, then Virtual Assistant
Intervention Description
instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).
Primary Outcome Measure Information:
Title
performance of healthcare workers
Description
Errors occurred during donning of PPE measured by procedure checklist
Time Frame
0- 30mins during donning
Title
performance of healthcare workers
Description
Errors occurred during doffing of PPE measured by procedure checklist
Time Frame
0- 30mins during doffing
Title
performance of healthcare workers
Description
Errors occurred during intubation measured by procedure checklist
Time Frame
0- 30mins during intubation
Title
performance of healthcare workers
Description
Errors occurred during extubation measured by procedure checklist
Time Frame
0- 30mins during extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Only anesthesia attending staff are allowed in the phase 1 study. Any working anesthesia staff and fellow, anesthesia assistant, respiratory assistant and operating room nurse are qualified to take part in phase 2 of this study. However, only anesthesia staff and fellows and anesthesia assistants will participate in the part that involves intubation and extubation. Exclusion Criteria: • Unwillingness to enter the study for phase 1 or phase 2.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongyu ( Cindy) Jin
Phone
416-603-5800
Ext
2016
Email
rongyu.jin@uhn.ca
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
ON M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongyu Jin
Email
rongyu.jin@uhn.ca

12. IPD Sharing Statement

Learn more about this trial

Virtual Assistant for COVID-19 PPE

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